Foster and Thrive Daytime Cold and Flu Relief Nighttime Cold and Flu Relief

Description

Acetaminophen, dextromethorphan HBr, and phenylephrine HCl are the active ingredients in this formulation, which serves as a pain reliever, fever reducer, cough suppressant, and nasal decongestant. The product is designed to provide multi-symptom relief for conditions such as aches, fever, sore throat, nasal congestion, cough, and headache. It is alcohol-free, antihistamine-free, and gluten-free, and is formulated to be non-drowsy. The product is available in a dosage form of 32 softgels, with the actual size of the softgels specified.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, fever, as well as runny nose and sneezing.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should take the medication only as directed, adhering to the overdose warning. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is two softgels taken with water every six hours.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing recommendations.

The medication is not indicated for use in children under 4 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease, as the combination may lead to serious adverse effects. Verification of MAOI status with a healthcare provider is recommended if there is any doubt.

• History of allergic reaction to this product or any of its ingredients, as this may result in severe allergic responses.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is imperative to monitor patients for signs of liver dysfunction, particularly in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician without delay.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, a persistent cough due to smoking, asthma, or emphysema, or difficulty urinating due to an enlarged prostate gland. Additionally, patients should be cautioned to seek guidance from a doctor or pharmacist if they are taking sedatives, tranquilizers, or the anticoagulant warfarin.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222, regardless of whether they exhibit signs or symptoms of overdose.

Discontinuation of Use Patients must be advised to stop taking this product and consult a doctor if pain or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms develop, or if a cough recurs alongside a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the risk of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Participants should also be vigilant for symptoms indicating a serious condition, such as a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. In such cases, consulting a healthcare provider promptly is advised.

Common adverse reactions may include excitability, particularly in children, and marked drowsiness. Patients are cautioned to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Care should be taken when driving or operating machinery due to the potential for increased sedation.

Patients are advised to stop use and consult a doctor if pain or cough worsens or lasts more than seven days, if fever worsens or persists for more than three days, if redness or swelling occurs, or if new symptoms develop. Additionally, if a cough recurs or is accompanied by a rash or headache that lasts, medical evaluation is warranted.

Before using this product, patients with liver disease, glaucoma, chronic cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, persistent cough due to smoking, asthma, or emphysema, or difficulty urinating due to an enlarged prostate gland should seek medical advice. Furthermore, individuals taking sedatives, tranquilizers, or the blood-thinning medication warfarin should consult a healthcare professional or pharmacist prior to use.

Drug Interactions

The concomitant use of this product with certain medications may lead to significant interactions that require careful consideration.

Anticoagulants The use of this product alongside warfarin, an anticoagulant, may elevate the risk of bleeding. Patients should be monitored closely for signs of increased bleeding and dosage adjustments may be necessary based on clinical judgment.

Monoamine Oxidase Inhibitors (MAOIs) Patients currently taking prescription monoamine oxidase inhibitors (MAOIs) for depression, psychiatric, or emotional conditions, or for Parkinson’s disease should avoid using this product. It is advised to refrain from using this product for at least two weeks following the discontinuation of an MAOI to prevent potential adverse effects.

CNS Depressants The co-administration of this product with alcohol, sedatives, or tranquilizers may enhance drowsiness. Patients should be advised to exercise caution when engaging in activities that require alertness, and monitoring for increased sedation may be warranted.

Packaging & NDC

Below are the non-prescription pack sizes of Foster and Thrive Daytime Cold and Flu Relief Nighttime Cold and Flu Relief (acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. The product is contraindicated in children under 4 years of age.

For dosing, adults and children aged 12 years and older are directed to take 2 softgels with water every 6 hours for nighttime cold and flu symptoms, and every 4 hours for daytime cold and flu symptoms.

In the event of an overdose, prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

Geriatric Use

There is no specific geriatric use information, dosage adjustments, or safety concerns for elderly patients mentioned in the provided text. Therefore, healthcare providers should consider the absence of data when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the general considerations for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have liver disease or experience difficulty urinating due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's overall health status and specific renal capabilities.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed 4,000 mg of acetaminophen in a 24-hour period, as exceeding this dosage can lead to significant hepatic injury. Additionally, the concurrent use of other medications containing acetaminophen or the consumption of three or more alcoholic drinks daily while using this product may further increase the risk of liver damage.

Patients with known liver disease are advised to consult a healthcare professional prior to using this product. This recommendation applies to both Nighttime Cold & Flu and Daytime Cold & Flu formulations, emphasizing the importance of medical guidance in this population to ensure safety and appropriate management of their condition. Regular monitoring of liver function may be warranted in patients with compromised liver function who are prescribed this product.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary, and early recognition and management are essential to mitigate potential complications. It is recommended that healthcare providers remain vigilant and prepared to initiate appropriate treatment protocols based on the specific circumstances of the overdose.

Nonclinical Toxicology

No specific teratogenic effects have been identified in the studies conducted. Similarly, there are no reported non-teratogenic effects associated with the compound. The available data do not provide specific details regarding nonclinical toxicology. Additionally, there are no defined findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse events reported voluntarily or through surveillance programs. Severe skin reactions, including symptoms such as skin reddening, blisters, and rash, have been associated with acetaminophen use. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, excitability has been noted, particularly in pediatric populations. Marked drowsiness is another reported effect, which may be exacerbated by the concurrent use of alcohol, sedatives, or tranquilizers.

Patients are advised to monitor for worsening pain or cough that persists beyond 7 days, as well as fever that lasts more than 3 days. The presence of redness or swelling, the emergence of new symptoms, or a cough that recurs alongside a rash or headache that persists may indicate a serious underlying condition, warranting further medical evaluation.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any noticeable signs or symptoms of overdose. This proactive approach can significantly impact the outcome in such situations.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

Patients should be advised on the appropriate route, method, and frequency of administration for the Nighttime and Daytime Cold & Flu formulations. For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 6 hours for Nighttime Cold & Flu and every 4 hours for Daytime Cold & Flu. For children aged 4 to under 12 years, consultation with a healthcare professional is necessary, and the product should not be used in children under 4 years of age.

Clinicians should counsel patients who are pregnant or breastfeeding to seek advice from a health professional before use. It is essential to keep the product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

This file contains official product information for Foster and Thrive Daytime Cold and Flu Relief Nighttime Cold and Flu Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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